When results from clinical trials suggest that one of our investigational medicines may offer benefits for patients facing life-threatening conditions, Merck is committed to bringing that medicine to those patients as quickly and equitably as possible. Participation in clinical trials should be the primary route by which patients get access to investigational medicines and contribute to the collection of safety and efficacy data needed to support regulatory approval worldwide. These clinical studies are needed to demonstrate that the medicine meets the standards for safety and efficacy that government regulatory agencies have established for granting approval. Gaining regulatory approval for a medicine is the best way to bring rapid access to the greatest number of patients who may benefit.
For patients with a serious or life-threatening disease who are ineligible or unable to participate in a clinical trial, use of an expanded access program may be an option. Depending on country regulations and the program criteria, access to investigational medicines may be provided through Expanded Access Programs (EAP) (known as compassionate use programs in certain jurisdictions), or Country-Specific Authorization to Use cohorts.
The following criteria must be met before Merck will consider establishing an EAP for a Merck investigational product:
Patients should consult with their healthcare provider about their eligibility to enroll in any of Merck's clinical trials and expanded access programs. To get more information about available Merck clinical trials, vist Merck Clinical Trials.
If the physician feels that the patient is not able to participate in an available clinical trial and that an expanded access program may be suitable for the patient, the physician should contact Merck to make the request on behalf of the patient. This will enable the physician to work with experts within the company to determine the appropriate course of action. Physicians seeking help on behalf of their patients in the U.S. may contact the Merck National Service Center (MNSC) at +1-800-672-6372. If a program exists, information will be provided to the requestor at the time of the call. If no program exists, the request will be acknowledged and noted.